Double‐blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients
Identifieur interne : 001F18 ( Main/Corpus ); précédent : 001F17; suivant : 001F19Double‐blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients
Auteurs : Matthew B. Stern ; Kenneth L. Marek ; Joseph Friedman ; Robert A. Hauser ; Peter A. Lewitt ; Daniel Tarsy ; C. Warren OlanowSource :
- Movement Disorders [ 0885-3185 ] ; 2004-08.
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Abstract
Rasagiline (N‐propargyl‐1(R)‐aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase‐B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel‐group, double‐blind, randomized, placebo‐controlled, 10‐week study. Fifty‐six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3‐week dose‐escalation period was followed by a 7‐week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were −1.8 (±1.3), −3.6 (±1.7), −3.6 (±1.2), and −0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline‐treated and placebo‐treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD. © 2004 Movement Disorder Society
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DOI: 10.1002/mds.20145
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This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel‐group, double‐blind, randomized, placebo‐controlled, 10‐week study. Fifty‐six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3‐week dose‐escalation period was followed by a 7‐week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were −1.8 (±1.3), −3.6 (±1.7), −3.6 (±1.2), and −0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline‐treated and placebo‐treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD. © 2004 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Matthew B. Stern MD</name><affiliations><json:string>University of Pennsylvania, Philadelphia, Pennsylvania, USA</json:string></affiliations></json:item><json:item><name>Kenneth L. Marek MD</name><affiliations><json:string>Yale University School of Medicine, New Haven, Connecticut, USA</json:string></affiliations></json:item><json:item><name>Joseph Friedman MD</name><affiliations><json:string>Brown University School of Medicine, Providence, Rhode Island, USA</json:string></affiliations></json:item><json:item><name>Robert A. Hauser MD</name><affiliations><json:string>University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Peter A. LeWitt MD</name><affiliations><json:string>Departments of Neurology, Psychiatry and Behavioral Neuroscience, Wayne State University School of Medicine, Detroit, and Clinical Neuroscience Center, Southfield, Michigan, USA</json:string></affiliations></json:item><json:item><name>Daniel Tarsy MD</name><affiliations><json:string>Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA</json:string></affiliations></json:item><json:item><name>C. 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This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel‐group, double‐blind, randomized, placebo‐controlled, 10‐week study. Fifty‐six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3‐week dose‐escalation period was followed by a 7‐week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were −1.8 (±1.3), −3.6 (±1.7), −3.6 (±1.2), and −0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P > 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline‐treated and placebo‐treated patients were similar. 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Warren</givenNames><familyName>Olanow</familyName><degrees>MD, FRCP</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>University of Pennsylvania, Philadelphia, Pennsylvania, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>Yale University School of Medicine, New Haven, Connecticut, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Brown University School of Medicine, Providence, Rhode Island, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="US" type="organization"><unparsedAffiliation>Departments of Neurology, Psychiatry and Behavioral Neuroscience, Wayne State University School of Medicine, Detroit, and Clinical Neuroscience Center, Southfield, Michigan, USA</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="US" type="organization"><unparsedAffiliation>Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="US" type="organization"><unparsedAffiliation>Mount Sinai School of Medicine, New York, New York, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">rasagiline</keyword><keyword xml:id="kwd2">Parkinson's disease</keyword><keyword xml:id="kwd3">monoamine oxidase inhibitors</keyword><keyword xml:id="kwd4">monotherapy</keyword><keyword xml:id="kwd5">safety</keyword><keyword xml:id="kwd6">tolerability</keyword></keywordGroup><fundingInfo><fundingAgency>Teva Pharmaceuticals USA (Kulpsville, PA)</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Teva Pharmaceutical Industries, Ltd. (Petah Tikva, Israel)</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Rasagiline (<i>N</i>‐propargyl‐1(<i>R</i>)‐aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase‐B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel‐group, double‐blind, randomized, placebo‐controlled, 10‐week study. Fifty‐six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3‐week dose‐escalation period was followed by a 7‐week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were −1.8 (±1.3), −3.6 (±1.7), −3.6 (±1.2), and −0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (<i>P</i> < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline‐treated and placebo‐treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD. © 2004 Movement Disorder Society</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Double‐blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Rasagiline in Early Parkinson's Disease</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Double‐blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients</title></titleInfo><name type="personal"><namePart type="given">Matthew B.</namePart><namePart type="family">Stern</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>University of Pennsylvania, Philadelphia, Pennsylvania, USA</affiliation><description>Correspondence: Pennsylvania Hospital, 330 South Ninth Street, Philadelphia, PA 19107</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kenneth L.</namePart><namePart type="family">Marek</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Yale University School of Medicine, New Haven, Connecticut, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Joseph</namePart><namePart type="family">Friedman</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Brown University School of Medicine, Providence, Rhode Island, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert A.</namePart><namePart type="family">Hauser</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Peter A.</namePart><namePart type="family">LeWitt</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Departments of Neurology, Psychiatry and Behavioral Neuroscience, Wayne State University School of Medicine, Detroit, and Clinical Neuroscience Center, Southfield, Michigan, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Daniel</namePart><namePart type="family">Tarsy</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C. Warren</namePart><namePart type="family">Olanow</namePart><namePart type="termsOfAddress">MD, FRCP</namePart><affiliation>Mount Sinai School of Medicine, New York, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2004-08</dateIssued><dateCaptured encoding="w3cdtf">2003-08-13</dateCaptured><dateValid encoding="w3cdtf">2004-02-20</dateValid><copyrightDate encoding="w3cdtf">2004</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">3</extent><extent unit="tables">3</extent><extent unit="references">32</extent><extent unit="words">5061</extent></physicalDescription><abstract lang="en">Rasagiline (N‐propargyl‐1(R)‐aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase‐B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel‐group, double‐blind, randomized, placebo‐controlled, 10‐week study. Fifty‐six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3‐week dose‐escalation period was followed by a 7‐week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were −1.8 (±1.3), −3.6 (±1.7), −3.6 (±1.2), and −0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline‐treated and placebo‐treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD. © 2004 Movement Disorder Society</abstract><note type="funding">Teva Pharmaceuticals USA (Kulpsville, PA)</note><note type="funding">Teva Pharmaceutical Industries, Ltd. (Petah Tikva, Israel)</note><subject lang="en"><genre>Keywords</genre><topic>rasagiline</topic><topic>Parkinson's disease</topic><topic>monoamine oxidase inhibitors</topic><topic>monotherapy</topic><topic>safety</topic><topic>tolerability</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>19</number></detail><detail type="issue"><caption>no.</caption><number>8</number></detail><extent unit="pages"><start>916</start><end>923</end><total>8</total></extent></part></relatedItem><identifier type="istex">06152E8AE57392DB334A8634EF1C90F690645F8A</identifier><identifier type="DOI">10.1002/mds.20145</identifier><identifier type="ArticleID">MDS20145</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2004 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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